Back to search results

PROFEMUR® Preserve Classic Femoral Stem Study

This study is looking at the safety and effectiveness of the PROFEMUR® Preserve Classic Femoral Stem, a hip replacement implant. It's a follow-up study required by European regulators for devices already approved. You can join if you have already had, or are planning to have, a total hip replacement using the PROFEMUR® Preserve Classic Stem along with other specific hip replacement parts from Wright Medical Technology or MicroPort Orthopedics Inc. The main goal is to see how well the implant lasts over 10 years. The study is currently observational, meaning researchers will be watching how the implant performs in real-world use.

Study design
This is an observational study with a planned enrollment of 150 participants. It is designed to evaluate the hip replacement implant in a single group of patients.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 10 years after their surgery to assess how long the implant components last.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04147559

Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem

Enrolling by Invitation
Not specifiedAges 21+Observational
MicroPort Orthopedics Inc.
~150 participants
Updated 2024-03-20 on ClinicalTrials.gov
What's tested:Total Hip Arthroplasty Implant

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Component Survivorship
Measured over 10 years post-operative

Conditions

Joint Diseases

Explore related trials

Acetabular ProtrusionAnkylosisAvascular NecrosisOsteoarthritisPainful Hip DysplasiaRheumatoid Arthritis

NCT04147559

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • HCA Research Institute, OrthoONE at Swedish Medical Center

    Englewood, Coloradono site contact published

  • HonorHealth Research Institute

    Scottsdale, Arizonano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Joseph Assini, MD · PRINCIPAL_INVESTIGATOR · OrthoOne at Swedish Medical Center
  • Judd Cummings, MD · PRINCIPAL_INVESTIGATOR · HonorHealth Research Institute

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis;
correction of functional deformity 3. Willing and able to complete required study visits and assessments through the 10 year postoperative follow-up visit 4. Previously implanted subjects must be enrolled within 3 years of their primary THA implantation.

What this trial measures

  • Component Survivorship10 years post-operative

    The primary objective of this study is to estimate component survivorship of the PROFEMUR® Preserve Classic Femoral Stem out to 10 years follow-up.